Holder for dual optic IOL

ABSTRACT

The present invention provides a holder/package for supporting a two optic accommodating intraocular lens device. The holder/package is capable of holding the device, for example while taking measurements or performing manufacturing process steps on the device and/or for packaging and shipping of the device. In a preferred embodiment, the holder/package supports the device along first and second haptics thereof with the optics substantially untouched by the holder/package.

BACKGROUND OF THE INVENTION

The present invention relates to devices and methods for holding and/orpackaging optical lenses such as intraocular lenses. More particularly,the present invention relates to a holder and/or packaging device andmethod for safely supporting an accommodating intraocular lens devicehaving at least two optics interconnected by one or more haptics.

Intraocular lenses having a single optic have been known and used formany years. More recently, accommodating intraocular lens devices havingtwo optics interconnected by one or more haptics have been disclosed inthe following U.S. patents and applications to Faezeh Sarfarazi, theentirety of which are incorporated herein by reference:

-   U.S. Pat. No. 5,275,623 “Elliptical Accommodative Intraocular Lens    For Small Incision Surgery”;-   U.S. Pat. No. 6,423,094 “Accommodative Lens Formed From Sheet    Material”;-   U.S. Pat. No. 6,488,708 “Open Chamber Elliptical Accommodative    Intraocular Lens System”;-   U.S. Ser. No. 10/445,762 filed on May 27, 2003 entitled “Mold for    Intraocular Lens”.

The Sarfarazi accommodating lens device includes two optics, onenegative and the other positive for placing in the evacuated lenscapsule of an eye. The optics are interconnected along their peripheriesby one or more haptics which space the optics from each other and assistin properly positioning the device in the eye. The haptics are formedfrom a flexible material such that they may flex in response to forcesexerted by the eye's ciliary muscles which control accommodation. Thehaptics will thus flex and bow further radially outwardly upon acompressive force being applied to the device, whereby the two opticsare drawn closer together to achieve an accommodative effect in the eye.When the ciliary muscles relax, the haptics flex in the oppositedirection (toward a straightened positioned) causing the optics to spacefurther apart and the lens device returns the eye to its natural,unaccommodative state.

As stated above, single optic intraocular lenses have been known andused for decades while the two lens accommodative intraocular lensdevice is new and not yet seen on the market. It will be appreciatedthat manufacturing, packaging and otherwise handling a two optic lensdevice presents issues not present in the manufacture, packaging andhandling of single optic intraocular lenses. For example, during designand manufacture of intraocular lenses, certain measurements andprocesses may be performed on the device to ensure the device achievesits design parameters. Typically such measurements and processes requirethe two optics of the device be held in their normally spaced apartcondition since contacting of the optical surfaces with each other orwith parts of the holder could damage the delicate lenses. Likewise,packaging of a two optic IOL requires the two optics of the lens remainin their normally spaced apart condition and free from contact with anypart of the package which could otherwise occur due to vibration andforces during transportation and handling.

SUMMARY OF THE INVENTION

The present invention provides a holder and/or package for safelysupporting a two optic accommodating intraocular lens device. In apreferred embodiment, the holder acts as the package for storage andshipment of the IOL device to a surgeon. The holder/package includes abase with spaced support posts extending substantially perpendicularlytherefrom which removably support the haptics of the IOL device. Theposterior optic and anterior optic extend freely therefrom in theirnormally spaced condition and substantially untouched by the holder. Inan advantageous embodiment, the holder acts as the package for storingand shipping the IOL device to a surgeon while maintaining the optics intheir spaced condition.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1A is a perspective view of an embodiment of an accommodativeintraocular lens which may be supported by the holder of the presentinvention;

FIG. 2 is a perspective view of an embodiment of the inventive holder;

FIG. 3 is a side elevational view of the holder of FIG. 2 showing thelens of FIG. 1 and the cover in spaced relation to the holder base;

FIG. 4 is a perspective view of the holder base showing the lens of FIG.1 spaced above the support posts thereof;

FIG. 5 is a perspective view the holder base showing the lens of FIG. 1mounted to the support posts thereof;

FIG. 6 is a side elevational view of FIG. 5;

FIG. 7 is a perspective view showing the bottom of the holder base;

FIG. 8 a is a perspective view of an alternate embodiment of the holderbase;

FIG. 8b is a cross-sectional view taken generally through the line 8 b-8b of FIG. 8 a;

FIG. 9 is a further alternate embodiment of the holder base; and

FIG. 10 is a further alternate embodiment of the holder base and cap.

DETAILED DESCRIPTION

Referring now to the drawing, there is seen in FIG. 1 a representativeembodiment of an accommodative intraocular device 10 which may be usedwith the present invention. Briefly, lens device 10 includes first andsecond optics 12, 14 interconnected by one or more, but preferably threehaptics 16 a, 16 b and 16 c defining three open spaces 18 a, 18 b, 18 ctherebetween, respectively. Haptics 16 a-c bow outwardly past the opticperimeters 12 p, 14 p and are flexible whereby the optics may movealternately toward and away from each other generally along the opticalaxis x-x. Optics 12, 14 are preferably flexible and may be made of anysuitable IOL lens material such as silicone, for example. It isunderstood that the present invention is a holder/package for a lensdevice and therefore the particular optic and haptic configurations of alens device which may be supported by the inventive holder/package mayvary from the exemplary lens shown and described herein.

Referring to FIGS. 2-7, a preferred embodiment of the holder/package isindicated generally by reference numeral 20. Holder/package 20 includesa base 22 and a removable cover 24 which may be made of any desiredmaterial such as plastic. If the holder/package is to be used tosterilize the lens 10 held thereby, holder/package 20 needs to be madeof a material that can withstand the sterilization method employed. Forexample, when using ETO sterilization, a plastic such as PVC may beused.

In the preferred embodiment, holder/package base 22 includes first andsecond lens supports 26, 28 extending substantially perpendicularly tobase 22. Supports 26, 28 are spaced apart a distance sufficient toenable the mounting of lens 10 thereto in the manner described below.Supports 26, 28 may have a variety of configurations but in theirpreferred form include bottom and top segments 26 a, 26 b and 28 a, 26b, respectively where top segments 26 b, 28 b are configured with asmaller diameter than their respective bottom segments such that ashoulder 26 c, 28 c is formed at the juncture of the top and bottomsegments. Shoulders 26 c, 28 c form a ledge upon which the downwardlyfacing edges of haptics 16 a and 16 b may rest when lens 10 is mountedto supports 26, 28. To mount the lens 10 to holder/package 20, lens 10is initially positioned above supports 26, 28 as seen in FIGS. 3 and 4with one haptic 16 c facing downwardly between supports 26, 28 andhaptics 16 a, 16 b aligned above supports 26, 28, respectively. Lens 10is then lowered toward base 22 with haptics 16 a, 16 b passing outwardlyand over support top segments 26 b, 28 b until the downward facing edges16 a′, 16 b′ thereof come to rest on shoulders 26 c, 28 c, respectively.This fully mounted position of lens 10 on supports 26, 28 is seen inFIGS. 5 and 6. In this position, lower-most haptic 16 c is locatedbetween and untouched by supports 26, 28. It is furthermore preferablethat this haptic not contact base 22 which may include an opening 23between supports 26, 28 wherethrough haptic 16c may at least partiallyextend and freely move without touching the perimeter of the opening dueto the sizing and chamfered sides thereof (see FIGS. 4-7). Opening 23may also assist in passage of sterilizing media (e.g., steam) to lens10.

Although two haptics 16 a, 16 b are shown and described herein aslocating over supports 26, 28, it is noted that the two haptics may beformed as a single haptic which engages the supports 26, 28. As statedpreviously, the invention is not limited to the lens design shown hereinand may include one or more haptics of various configurations asdesired. In this respect, it is noted that the support top segments 26b, 28 b in particular may have any desired shape and cross-section tomore closely conform to the shape of the haptic(s) being locatedthereon.

With lens 10 mounted to supports 26, 28 as described above, optics 12,14 remain in their normally spaced position and substantially untouchedby holder/package 12. As seen best in FIG. 6, support top segments 26 b,28 b may be shaped to more closely conform to the shape of the facingsurfaces of the haptics 16 a, 16 b mounted thereon. More particularly,the outwardly facing surfaces 26 b′, 28 b′ of top segments 26 b, 26 bmay be curved to follow the curvature of the inwardly facing surfaces 16a′, 16 b′ of haptics 16 a, 16 b, respectively (see also FIG. 1). Asmentioned above, the spacing of supports 26, 28 enable lens 10 to bemounted thereon substantially as shown and described herein. In thisregard, it is noted that haptics 16 a, 16 b are preferably in close butnot overly tight engagement with support top segments 26 b, 28 b. Assuch, lens 10 remains in its normally relaxed condition with optics 12,14 spaced and lying substantially perpendicular to base 22. Optics 12,14 and haptics 16 a-c are preferably substantially unstressed whenmounted to supports 26, 28.

Once lens 10 is mounted to supports 26, 28, cover 24 may be removablysecured to base 22 over lens 10 and supports 26, 28 as seen in FIGS. 2and 3. Cover 24 protects lens 10 and preferably does not come intosubstantial contact therewith. The top portion 25 is attached to a skirt27 forming a space 29 wherein lens 10 and supports 26, 28 reside whencover 24 is attached to base 22. The space 29 is large enough toaccommodate lens 10 and supports 26, 28 therein, yet small enough toprevent lens 10 from inadvertently decoupling from supports 26, 28during handling or shipping. In this regard, when cover 24 is coupled tobase 22, the inside surface of top portion 25 lies in close proximity toupper-most parts 16 a″, 16 b″ of haptics 16 a, 16 b (FIG. 6), therebyacting as a stop against which haptic parts 16 a″, 16 b″ will abutshould they be urged in a direction off of supports 26 a, 28 b.

In its preferred form, cover top portion 25 is round and skirt 27 iscylindrical although other configurations are possible. One or moreopenings 29 a-c may be provided in top portion 25 and/or skirt 27 forpassage of sterilizing media therethrough. Releasable coupling means areprovided which may be in the form of first and second finger portions31, 33 extending downwardly from the free edge of skirt 27 whichcooperate with slots 35, 37 formed in base 22 radially outwardly ofsupports 26, 28, respectively. As seen best in FIG. 7, the free ends 31a, 33 a of finger portions 31, 33 extend through slots 35, 37 uponinitial attaching of cover 24 to base 22. Cover 24 is then rotated untilthe finger free ends 31 a, 33 a engage with the slot shoulders 35 a, 37a (FIG. 5) in the manner of a bayonet type coupling. To remove cover 24,the cover 24 is simply rotated in the opposite direction until thefingers disengage from the slot shoulders at which time cover 24 may beraised relative to base 22. Of course other types of removable couplingmeans may be employed.

A depression 21 or the like may be formed in base 22 to provide a spacein which lens 12 may be inspected and handled (e.g., with tweezers) onceremoved from supports 26, 28.

FIGS. 8 a and 8 b show an alternate embodiment of a base 122 havingfirst and second spaced supports 126, 128 extending substantiallyperpendicularly from a base 122. Base 122 includes a central circularportion 122 a surrounded by a circular wall portion 122 b. Supports 126,128 are spaced from wall portion 122 b forming a space 123, 125therebetween. Lens device 10 is mounted to base 122 by passing haptics16 a, 16 b over and about supports 126, 128 with the haptics 16 a, 16 bcoming to rest in spaces 123, 125, respectively, and optics 12, 14 lyingin their relaxed, spaced condition. As seen best in FIG. 8 b, the topextents of the outwardly facing surfaces of haptics 16 a, 16 b gentlyabut wall portion 122 b with the bottom extents thereof gently abuttingsupports 126, 128, respectively, thereby preventing lateral movement oflens device 10 along an axis intersecting supports 126, 128. Base 122thus supports lens device 10 by capturing the haptics between thesupports and wall portion with the optics 12, 14 lying spaced andsubstantially perpendicular to base central circular portion 122 a.Central circular portion 122 a may include a through hole 122 c to allowpassage of sterilizing media therethrough.

FIG. 9 shows yet another alternate embodiment of a base 222 having aunitary support 226 of generally planar configuration extendingsubstantially perpendicular to central base portion 222 a. Opposite sideedges 226 a, 226 b are spaced inwardly of wall portion 222 b whichencircles central portion 222 a. Support 226 may include a centralopening 226 c to provide clearance between the support 226 and optics12, 14 of the lens device 10. Lens device 10 is mounted thereto bypassing haptics 16 a, 16 b over and about opposite side edges 226 a, 226b with the lower-most edges of haptics 16 a, 16 b coming to rest at thejuncture of side edges 226 a, 226 b and circular base portion 222 a,respectively. It is noted that while support 126 is a unitary structure,the opposite side edges 226 a, 226 b thereof may be considered as firstand second supports, respectively, as those terms are used elsewhereherein. The support top edge 226 d may be convexly curved to generallyfollow the inside contour of haptic 16 c resting thereon. When lensdevice 10 is mounted to support 226, optics 12, 14 lie spaced andsubstantially perpendicular to base portion 222 a.

FIG. 10 is yet a further alternate embodiment of a base 322 having firstand second supports 326, 328 over which haptics 16 a, 16 b may extend ina manner similar to the embodiments of FIGS. 2-9. One or more posts 330a-d extend substantially perpendicularly from base 322 on either side ofand spaced radially outwardly of supports 326, 328. Posts 330 a-d act tofurther guide and control the lateral movement of haptics 16 a, 16 bextending therebetween. An alternate configuration of cap 324 is alsoshown.

Although the invention has been described with reference to severalembodiments, it is understood that further variations may be madewithout departing from the full scope of the invention as defined by theclaims which follow.

1. A holder/package for an intraocular lens device having first andsecond optics interconnected by one or more haptics, said holder/packagecomprising: a) a base; b) first and second supports attached to saidbase; whereby said intraocular lens device may be removably mounted tosaid holder/package by engaging said one or more haptics with said firstand second supports, respectively, with said first and second opticslying spaced from each other and substantially perpendicular to saidbase.
 2. The holder/package of claim 1 wherein first and second hapticsinterconnect said first and second optics, and wherein said first andsecond haptics engage said first and second supports, respectively. 3.The holder/package of claim 2 wherein said supports are separated adistance permitting said intraocular lens device to be engaged therewithin a substantially unstressed condition.
 4. The holder/package of claim1 and further comprising a removable cover for attaching to said base incovering relation to said supports and said intraocular lens device. 5.The holder/package of claim 4 wherein said cover, when attached to saidbase, acts as a stop to prevent said intraocular lens from releasingfrom said supports.
 6. The holder/package of claim 4 wherein said coverand base are attached to each other with a bayonette-type coupling. 7.The holder/package of claim 1 wherein said first and second supportseach include a lower and upper segment having a shoulder formed at thejuncture of the lower and upper segment.
 8. The holder/package of claim5 wherein said one or more haptics extend around said supports and reston said shoulders when said intraocular lens device is mounted to saidsupports, respectively.
 9. A method for holding an intraocular lensdevice having first and second optics interconnected by one or morehaptics, said method comprising the steps of: a) providing a base; b)providing first and second supports attached to said base; c) removablymounting said one or more haptics of said intraocular lens device tosaid first and second supports, respectively, whereby said first andsecond optics are spaced from each other.
 10. The method of claim 9wherein first and second haptics are removably mounted to said first andsecond supports, respectively.
 11. The method of claim 10 wherein athird haptic extends between said first and second supports when saidintraocular lens device is mounted to said first and second supports,respectively.
 12. The method of claim 9 and further comprising the stepof providing a cover for removable attachment to said base in coveringrelation to said support and said intraocular device.